Management Challenges for FY 2011

On September 27, 2007, the President signed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title II of FDAAA, the Medical Device User Fee Amendments of 2007, reauthorizes medical device user fees for FY 2008 through FY 2012 (MDUFMA II). MDUFMA II calls for a new set of challenging performance goals and a new fee structure.

FDA will continue to monitor performance against the goals for the MDUFMA I cohorts that remain open (FY 2004 through FY 2007; the FY 2003 cohort is now closed) and against the new performance goals of MDUFMA II.

The performance goals for applications filed or accepted from FY 2008 through FY 2012 are defined in a September 27, 2007, letter from former HHS Secretary Michael O. Leavitt to Congress; see the following table for a summary of these goals.

An "FDA Decision" is any of the following: an approvable letter (including approvable pending GMP inspection), a non-approvable letter, a withdrawal, or a denial order.An “FDA Action” on a PMA module is any of the following: accepting the module, a request for additional information, receipt of the PMA, or withdrawal of the module.

These goals are structured in ways that differ from the goals for FY 2003 through FY 2007:

The FY 2008 – FY 2012 goals do not vary from one fiscal year to the next. Instead, each goal will apply throughout the five years from FY 2008 through FY 2012.

Except for PMA modules, all of FDA’s performance goals focus on making an “FDA decision” and FDA will not have any cycle goals. PMA decisions are approval, approvable, approvable pending Good Manufacturing Practices (GMP) inspection, not approvable, withdrawal, and denial. 510(k) decisions are substantially equivalent (SE) or not substantially equivalent (NSE).

For PMA modules only, FDA’s performance goals focus on FDA taking an “action” on the module. An “FDA action” on a PMA module is any of the following: accepting the module, a request for additional information, receipt of the PMA, or withdrawal of the module. PMA modules are not subject to a decision goal, because the modular submission is converted to a PMA upon submission of the final module.

Each goal has two tiers, and all submissions are measured in both tiers. Compared with the lower tier, the upper tier of each goal provides for additional review time, but requires a higher percentage of reviews to have an FDA decision (or, in the case of PMA modules, an FDA action) within the specified review time. The use of two tiers helps ensure that FDA focuses on all applications within a cohort, rather than just those that are most likely to reach an FDA decision quickly.